Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441870
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):

Brief Summary:
This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Condition or disease Intervention/treatment Phase
Cancer Drug: EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate) Drug: 99mTC-EC20 (Folic acid-technetium 99m conjugate) Phase 1

Detailed Description:
This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle
Study Start Date : February 2007
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)
    Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)
    Other Name: Folic acid desacetylvinblastine hydrazide conjugate
    Drug: 99mTC-EC20 (Folic acid-technetium 99m conjugate)
    20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging
    Other Names:
    • Folic acid-technetium 99m conjugate
    • FolateScan

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients ]

Secondary Outcome Measures :
  1. Pharmacokinetic and pharmacodynamic parameters [ Time Frame: Obtained during the first cycle of therapy on Days 1 and 3 ]
  2. Anti-tumor activity [ Time Frame: Initial dose of study therapy to disease progression ]
  3. Uptake of 99mTc-Ec20 in tumors and normal tissues [ Time Frame: 1-2 hours post-administration of 99mTc-EC20 ]
  4. Safety and tolerability [ Time Frame: Initiation of study therapy through 30 day post last dose of study therapy ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older
  • Histological or cytological diagnosis of neoplasm
  • No effective standard therapeutic options
  • ECOG performance status of 0-2
  • ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
  • Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
  • Adequate bone marrow reserve, renal and hepatic function

Exclusion Criteria:

  • Concurrent malignancies
  • Women who are pregnant or lactating
  • Evidence of symptomatic brain metastases
  • Receiving concomitant anticancer therapy (excluding supportive care)
  • Requires palliative radiotherapy at time of study entry
  • Unable to tolerate conditions for radionuclide imaging
  • Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00441870

United States, Maryland
Greenebaum Cancer Center - University of Maryland Medicine
Baltimore, Maryland, United States, 21201
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Sponsors and Collaborators
Study Director: Richard A. Messmann, MD, MHS, MSc Endocyte

Responsible Party: Endocyte Identifier: NCT00441870     History of Changes
Other Study ID Numbers: EC-0225-01
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Endocyte:
Phase 1

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs